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CONTROCAR nail enamel remover

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					Instruction for use and expert information
CONTROCAR
Active ingredient: sodium fluoride

Composition

Active Ingredients

1 ml of dental suspension contains 50 mg of sodium fluoride (corresponding to 22.6 mg of fluoride)

Additives

Canada balsam and butane-2-one

Presentation and Package Size

10 ml of dental suspension
Dental caries prophylaxis

lege artis Pharma GmbH + Co KG
P. O. Box 60, D-72132 Dettenhausen
Breitwasenring 1, D-72135 Dettenhausen
Telephone +49 (0) 71 57 / 56 45 - 0
Fax +49 (0) 71 57 / 56 45 50
E-Mail: info@legeartis.de

Indications

CONTROCAR serves the prevention of dental caries, especially in sites of raised susceptibility to caries (e.g. brace-bearing
teeth in patients with dental braces, other orthodontic appliances or partial dentures).
CONTROCAR serves the treatment of hypersensitive dental necks.
CONTROCAR serves in support of the treatment of primary dental caries (remineralisation).

Contraindications

In patients with a known hypersensitivity to one of the ingredients, CONTROCAR must not be used.
In patients, in whom the control of the swallowing reflex is not guaranteed (e.g. children prior to their enrolment in school,
handicapped people) exactly dosable alternatives such as NaF-tablets should be preferred.

Application precautions

In the case of a systemic fluoride administration (e.g. fluoride tablets or fluoridated common salt) this should be discontinued
for some days following the application of CONTROCAR.

Drug Interactions

None known


Warning

The liquid is easily inflammable and hence should not come into contact with open flames.

Dosage instructions, mode and duration of application

The amount of CONTROCAR required depends on the local factors.
Immerse an Apply-Tip once and dab three times. This corresponds to ca 3 times 0.03 ml of CONTROCAR which is
equivalent to 3 x 0.68 mg of fluoride, hence a total of ca 2 mg of fluoride.
Dry the tooth surface after thorough cleaning. Before use, shake CONTROCAR well until the sodium fluoride particles are
evenly distributed in the liquid.
Immerse an Apply-Tip once and dab three times to produce a sufficiently thick coating.
Allow to dry after each dabbing. Do not dry with the air-syringe or the active particles will be unevenly distributed. The liquid
evaporates very quickly leaving a natural resin layer in which the sodium fluoride particles are embedded. The application
may be realised 4 to 6 times a year.
If the shaking up of the suspension causes any problems, we recommend to put the bottle with CONTROCAR into an
ultrasonic bath until the sediment will be completely dispersed.

Overdose and other dosage mistakes

In the extreme case and depending on the dosage, larger amounts of fluoride may be applied in the oral cavity. The
swallowing of such amounts may lead to nausea, vomiting, and diarrhoea.
The regular exceeding of a total daily intake of 2 mg of fluoride (systemically and locally) during the period of tooth
development may lead to disturbances in the mineralisation of the tooth enamel. This disturbance, also known as dental
fluorosis, manifests itself by mottled enamel.
An inadvertent overdosage by swallowing very large amounts may lead to hypocalcaemia and cardial disturbances.
Therapy:
Immediate sufficient supply of fluid per os in the form of milk, then induce vomiting by irritating the posterior pharyngeal wall.
Gastric lavages with an addition of calcium gluconate. Immediate intravenous injection of 20 ml of a 10% calcium gluconate
solution at 15- to 30-minute intervals monitoring the calcium level. As a prophylaxis of ventricular fibrillation lidocaine is
given. Shock treatment. Fluid- or electrolyte substitution.

Side Effects

When used as directed (see Dosage, Mode and Duration of Application), side effects have not become known.
In particular cases, hypersensitivity reactions (allergies) cannot be excluded.
Patients are asked to inform their dentist, if they notice any side effects, particular such which are not mentioned in this
leaflet.

Notes

CONTROCAR is to used up within four weeks after the first opening.
Do not use CONTROCAR after the expiry date, which is printed on the label and on the package.
Do not store above 25 °C.
After use, the CONTROCAR container must be tightly closed or the liquid will quickly evaporate.

Date of Current Information

April 2005



Additional informations for experts:


Pharmacological Characteristics, Toxicological Characteristics, Pharmakokinetic

The following partial components essentially constitute the mechanism of protective               effect:

  -          Increased resistance to the decay of the dental hard substance by acidic noxae generated in the plaque as, for
             example, through the bacterial breakdown of sugar-containing substrates. This occurs by the incorporation of
             fluoride into the enamel crystals, which primarily consist of hydroxylapatite, with partial formation of a more
             resistant fluoroapatite.

  -          Promotion of the natural remineralisation of primary caries lesions by the saliva.

  -          Retarding effect on the sugar breakdown of acid-producing micro-organisms in the dental plaque.

A lasting success is only assured by a lifelong supply of fluoride in therapeutically effective dosages. In this case, frequent
doses of low-concentrated fluoride compounds are preferred to less frequent administrations of higher concentrations.
In sodium fluoride compounds, the cation has no influence on the caries-preventing effect.
Profiles of fluoride concentrations in the serum following the local application of fluoride-containing jellies, enamels or
solutions fundamentally differ from the course of concentrations which arise after swallowing, i.e. after the oral
administration without contact with tissues of the oral cavity.
Depending on the mode of application (brushing, enamelling), the retention capacity of the denture (influenced by the tooth
position, dental protheses, flow of saliva), material-specific features (adhesiveness, surface affinity) as well as other
individual factors, (e.g. consumption of food and drink), at different times varying portions of the fluoride impacted in the oral
cavity following the local application are desorbed from their supporting base,
swallowed, and absorbed. Therefore, statements on the moment and the height of peak concentrations are not possible.
If larger amounts of fluoride are swallowed during the application, serum concentrations may be attained which exceed the
                                                               -
values following the oral application of 1 or 2 mg of fluoride (e.g., in the form of NaF-tablets).
To sum up, it can be said that in no case toxic concentrations in the serum will arise when the said ingredient is used as
directed.

Further notes

Children aged under 6 years should not be treated with CONTROCAR.
To insure a long duration of action, the patient should not eat any solid food for some hours following the application to
avoid a premature abrasion of the natural resin coating.




Special advice for the patients’ acceptance

CONTROCAR shows an intensive signal-odour. For the patients’ better acceptance it has been proved useful to inform
them before the application of CONTROCAR that it will smell – for example – like nail polish remover.

                                                                 0022102/Stückzahl0405/Bestelldatum

				
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Description: CONTROCAR nail enamel remover